Speedel, Novartis: Phase 3 data on SPP100 to treat hypertension shows potential for first-in-class drug

By E. Janene Geiss

Philadelphia, May 17 - Speedel said Wednesday that detailed phase 3 clinical data on SPP100 (Rasilez) in the treatment of hypertension goes further than the summary findings released by Novartis in September 2005 and confirms the robust efficacy and safety profile of the drug both as a monotherapy and in co-administration with diuretic hydrochlorothiazide (HCTZ).

SPP100 is the first-in-class once daily oral renin inhibitor that Speedel successfully developed through phase 1 and 2 clinical trials before Novartis exercised its license-back option in 2002, according to a company news release.

The Food and Drug Administration in April accepted for review Novartis' New Drug Application for SPP100 as a treatment for hypertension both as monotherapy and in co-administration with other anti-hypertensives.

The application includes data from more than 6,000 patients with high blood pressure treated with SPP100 in 34 clinical trials, officials said.

"The quality and quantity of the clinical data now available on SPP100 underlines its potential as the 'first-in-class' novel therapy for hypertension for over a decade," Jessica Mann, Speedel medical director, said in the release.

The data was presented Wednesday in New York at the annual scientific meeting and exposition of the American Society of Hypertension.

In phase 3 clinical trials, SPP100 showed significant reduction in mean 24-hour ambulatory blood pressure at dosages ranging from 150 to 600 mg once daily. The drug rendered effective blood pressure reduction that was maintained throughout the 24-hour dosing period, which persisted overnight and throughout the high-risk period in the early hours of the morning, officials said.

These data suggest that once-daily SPP100 has the potential to maximize end-organ protective benefits through continuous, smooth blood pressure lowering when administered as a once-daily monotherapy at dosages ranging from 150 to 600 mg, officials said.

The development of SPP100 is the result of more than 20 years of research on renin. Renin is the key enzyme at the top of the Renin Angiotensin System, one of the key regulators of blood pressure, officials said.

Speedel in-licensed SPP100 from Novartis in 1999 and successfully completed 18 clinical trials through phase 1 and 2 in about 500 patients and healthy volunteers.

Based on the results generated during this program, Novartis exercised a license-back option in 2002. In March 2004, Novartis started trials with SPP100 in phase 3 as monotherapy for hypertension and in phase 2b as combination therapy.

Phase 3 trials are ongoing in the United States, European Union and Japan, with first regulatory submission in the United States already filed in the first quarter of 2006 and planned in the European Union during 2006, officials said.

Speedel is a Bridgewater, N.J., biopharmaceutical company that develops therapies for cardiovascular and metabolic diseases.

Novartis is a Basel, Switzerland, pharmaceutical and health care products company.

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